Regulatory requirements in the preparation CTD and ECTD as Per CDSCO comparison with Brazil
Department of Regulatory Affairs, Sree Siddaganga College of Pharmacy, 1st left cross, 3rd block, Mahalakshmi nagara, Near railway gate, 80 feet road Batwadi, Tumkuru – 572103, Karnataka, India.
Review Article
World Journal of Advanced Research and Reviews, 2023, 20(02), 046–053
Publication history:
Received on 02 September 2023; revised on 15 October 2023; accepted on 18 October 2023
Abstract:
Stringent regulatory standards apply to the creation of Common Technical Documents (CTD) and Electronic Common Technical Documents (eCTD) for regulatory submissions in India, which are overseen by the Central Drugs Standard Control Organization (CDSCO). The essential regulatory considerations affecting the creation of CTD and eCTD submissions in accordance with CDSCO criteria are summarized in this abstract. It emphasizes how crucial adherence to these rules is to ensure the prompt and effective registration of pharmaceutical goods in India. The advantages of eCTD in simplifying the regulatory process are also briefly covered in the abstract, along with the changing environment of electronic submissions. For pharmaceutical businesses seeking market authorisation in India and for regulators striving to maintain the highest standards, understanding and adherence to CDSCO's regulatory requirements are essential.
Keywords:
CTD is for Common Technical Documents; ECTD stands for Electronic Common Technical Documents; Central Drugs Standard Control Organization stands for central Drugs Standard Control Organization
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